Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy

Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy - Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy(KBCSG01)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004340

Enrollment

Registered

2010-10-06

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

S-1 is administered orally at 80 mg/m2 for 28 consecutive days followed by a 14 days rest. Cycles are repeated every 6 weeks until 4 courses.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Pathologically proven primary female breast cancer 2)stage I-IIIA patients who underwent curative operation 3)Patients with histologically diagnosed residual invasive cancer after preoperative chemotherapy 4)HER2 negative 5)low expression of ER and PgR 6)age: >=20 and <=70 7)Performance Status: 0-1(ECOG) 8)No-carry-over effect of prior treatment 9)sufficient function of important organs a)WBC: >=3,000/mm3 b)Neutrophyl: >=1,500/mm3 c)Platelet: >=100,000/mm3 d)Hemoglobin: >=9g/dl e)GOT, GPT: <= 2.5 times of the upper limit of normal range in each institute f)ALP: <= 2.5 times of the upper limit of normal range in each institute g)sT.bil: <= 2.5 times of the upper limit of normal range in each institute h)Ccr: >=60 ml/min/body 10)written informed consent 11)with ability of oral intake

Exclusion criteria

Exclusion criteria: 1)patients receiving oral 5-FU based chemotherapy 2)with active double cancer 3)with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis) 4) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 5)with history of mental disorder or treating it at the moment 6)with history of severe allergy 7)with severe allergy to 5-FU based drug 8)patients receiving 5-FU based chemotherapy 9)patients receiving Flucytosine 10)Bilateral breast cancer, either simultaneous or metachronal 11)inflammatory breast cancer 12)Impossible to take oral drugs 13)doctor's decision not to be registered to this study

Design outcomes

Primary

Measure	Time frame
feasibility, safety	—

Secondary

Measure	Time frame
disease free survival, overall survival, drug compliance	—

Countries

Japan

Contacts

Public ContactYoshimasa Kosaka

Kitasato University School of Medicine Department of Surgery

y-kosaka@med.kitasato-u.ac.jp0427788111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026